Theriva Biologics, Inc. · AMEX:TOVX
Theriva Biologics — Synthetic Biologics — Investor Presentation (March 2014)
31 slides from Theriva Biologics's investor presentation, Mar 4, 2014
Slide 1: Synthetic Biologics March 2014
oe NYSE MKT: SYN ©) SYNTHETIC March 2014
Slide 2: Forward-Looking Statements
Forward - Looking Statements This presentation includes forward - looking statements on Synthetic Biologics’ current expectations and projections about future events . In some cases forward - looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expec
Slide 3: Investment Proposition
Investment Proposition • Building portfolio of anti - infective biologics and drugs targeting specific pathogens that cause serious infections and other diseases ̶ Innovative, first - in - class product candidates for prevention and treatment ̶ Large markets ̶ Shorter treatment period may reduce cli
Slide 4: Management Team
Management Team 4 • Jeffrey Riley, CEO Pfizer, Nichols Institute (Quest), SmithKline Beecham, QIC • C. Evan Ballantyne , CFO Clinical Data, Inc., Avedro , ZymeQuest , ACNielsen, IMS • John Monahan, Ph.D., EVP R&D Avigen , Somatix , Triton Biosciences, Hoffman - LaRoche • Michael Kaleko, M.D., Ph.D .
Slide 5: Product Pipeline
Product Pipeline 5 NYSE MKT: SYN * - SYN - 004, 2 nd generation oral enzyme candidate under development based on 1 st generation candidate (P1A) Phase II results I - Intrexon collaboration – design, engineering and optimization of lead candidates T - The University of Texas at Austin – antibody rese
Slide 6: Estriol 'Pregnancy Hormone' – Linked to decreased MS relapse rates
Estriol “Pregnancy Hormone” – Linked to decreased MS relapse rates • Estriol − Hormone produced by placenta during pregnancy with highest level in 3 rd trimester − Large safety database exists from prior foreign approvals for treatment of post - menopausal symptoms • Landmark observational study pub
Slide 7: MS: Relapsing-Remitting MS Phase II Clinical Trial of Trimesta
MS: Relapsing - Remitting MS Phase II Clinical Trial of Trimesta TM (oral estriol) • Multi - center, investigator - initiated, randomized, double - blind, placebo - controlled trial 2 ̶ Relapse rates at 2 years of oral Trimesta / Copaxone ® vs. placebo/ Copaxone ® • Trial status ̶ Enrollment complet
Slide 8: MS: Market
MS: Market • 400,000 MS patients in U.S. (~2.3 million worldwide) 4 • $14.1 billion current estimated worldwide sales 5 • Issued U.S. patent includes claims for use of Trimesta in combination with Copaxone ® Trimesta Opportunity – Oral add - on MS therapy 8 NYSE MKT: SYN Teva/Copaxone $4.178 30% Bio
Slide 9: Emerging Consensus on the Microbiome
Emerging Consensus on the Microbiome 9 SYN building portfolio of targeted, pathogen - specific novel drugs “Infections were the second leading cause of death worldwide in 2002 , killing nearly 15 million people – almost 1 in 3 deaths across the globe ” Brad Spellberg, M.D., Rising Plague 6 “ Your gu
Slide 10: Rebirth of Anti-Infective Sector
Rebirth of Anti - Infective Sector SYN: Building a robust portfolio of targeted anti - infectives 10 NYSE MKT: SYN • January 2014 AstraZeneca and FOB Synthesis R&D agreement for novel antibiotics • December 2013 The Medicines Company acquires Rempex Pharmaceuticals for $474M • November 2013 Shire ac
Slide 11: Clinical Success Rates by Therapeutic Area
Clinical Success Rates by Therapeutic Area 8 Phase I through Food & Drug Administration approval Aligns with SYN’s focus on the development of novel anti - infectives 11 NYSE MKT: SYN 0% 5% 10% 15% 20% 25% Nervous System Cardiovascular Respiratory Oncology Musculoskeletal Anti-Infective 8% 9% 10% 19
Slide 12: Three Domains of Life
12 Three Domains of Life Methanobrevibacter smithii : member of the Archaea domain NYSE MKT: SYN Cedars - Sinai and SYN strive to be leaders in the field of methanogen - related R&D
Slide 13: C-IBS: Role of methanogens
13 • Dr. Pimentel of Cedars - Sinai is a leading investigator in this field • Clear link between small intestinal bacterial overgrowth (SIBO) and disease • Methane levels in C - IBS are significantly higher • Methane slows intestinal transit causing constipation, bloating and abdominal pain • Microb
Slide 14: C-IBS: How do we intend to help patients?
14 • Use Rx/ Dx approach with SYN - 010 – Have both a diagnostic biomarker in the form of a methane breath test as well as a compound – Multiple clinical studies show reduction in methane gas in the small intestine improves patients’ lives • Treat the cause and not just the symptoms – Current therap
Slide 15: C-IBS and Tertiary Markets
15 • Up to $10 billion in direct costs to the U.S. healthcare system and up to $20 billion in indirect costs 9 • 40% of all IBS patients have C - IBS • ~$2.7 billion market expected by 2020 10 • Major IBS players include ‒ Salix ( rifaximin ) for diarrhea - predominant IBS (D - IBS) ‒ Ironwood/Fores
Slide 16: Paradigm Shift
Paradigm Shift Decrease in C. diff infections expected with co - administration of SYN - 004 NYSE MKT: SYN 16 Antibiotics Treatments • β - lactam • Fluoroquinolone • Clindamycin • Other • Metronidazole • Vancomycin • Fidaxomicin Current Paradigm SYN - 004 Paradigm C. diff Infections β - lactam Antib
Slide 17: SYN-004: Co-Administered with IV Antibiotics
SYN - 004: Co - Administered with IV Antibiotics Intended to neutralize effects of β - lactam antibiotics in GI tract 17 NYSE MKT: SYN SYN - 004 Antibiotic 1. SYN - 004 is being developed as an oral enzyme tablet ( blue) to be co - administered with IV antibiotics (yellow ). 3. SYN - 004 is intended
Slide 18: C. difficile (C. diff) Infections
18 • 24 million patients administered IV antibiotics annually in the U.S. 15 – 1.1 million patients infected with C. diff annually 16 – Patients with C. diff hospitalized approximately 4 - 7 extra days 17 – $ 8.2 billion in costs associated with C. diff - related stays in hospital 18 – 30,000 C. dif
Slide 19: SYN-004: Prophylactic treatment for prevention of C. diff infections
19 SYN - 004: Co - Administered with IV Antibiotics Prophylactic treatment for prevention of C. diff infections • Oral enzyme to be co - administered with penicillins or cephalosporins ( β - lactam antibiotics) ̶ Remain within the intestine to degrade certain IV β - lactam antibiotics ̶ Preventative
Slide 20: SYN-004: Market Potential
SYN - 004: Market Potential Intended to target certain IV β - lactam antibiotics NYSE MKT: SYN 20 14.4M patients 22 26.5M prescriptions 21 117.6M doses of “SYN - 004 target” β - lactam antibiotics purchased by U.S. hospitals to fill patient prescriptions 20 * Based on U.S. market data in 2012 ** Est
Slide 21: Pertussis Infections
Pertussis Infections Millions of whooping cough cases globally per year • Despite aggressive vaccination strategies, incidence of Pertussis is increasing 23,24 ̶ Less effective vaccine introduced in the 1990s ̶ Non - compliance with standard vaccinations ̶ ~41,000 cases per year in the U.S. 25 • Unv
Slide 22: Acinetobacter Infections
Acinetobacter Infections Infections increasing due to this pandrug - resistant gram - negative bacterium • M ortality rates as high as 43% reported 27 • Billion dollar market opportunity 28 • Survives on dry surfaces for up to 36 days ̶ Survives twice as long as non - biofilm - forming pathogens 29
Slide 23: SYN-007: Biologics for Specific Subset of IBS Patients
SYN - 007: Biologics for Specific Subset of IBS Patients Intrexon Collaboration 23 NYSE MKT: SYN • Discovery at Cedars - Sinai to be a form of small intestinal bacterial overgrowth (SIBO) ̶ SIBO caused by antibodies to food poisoning toxin (single incident) • Intend to focus upstream on intestinal h
Slide 24: Corporate Snapshot
Corporate Snapshot • Cash balance (as of 9/30/13 ) : ~$5.1 million • Capital raise (12/17/13 close) : ~$12.1 million net proceeds • Current Price : $2.70 (as of 2/28/14) • 52 Week Range: $0.95 - $3.05 • Average Volume (3 months): 913,228 • Shares Outstanding: ~58 million (as of 12/17/13) • Options O
Slide 25: Program Highlights
25 Program Highlights NYSE MKT: SYN • MS: Trimesta TM (oral estriol) in Phase II RRMS clinical trial Completed final patient, final 24 - month visit (January 2014) ‒ Report topline results at AAN – Lead PI, R. Voskuhl , M.D. (April 2014) ‒ Report detailed results – Lead PI, R. Voskuhl , M.D. (2H 201
Slide 26: Key Milestones: 2014 Timeline
2H 2014 C. difficile Initiate Phase Ia and Ib clinical trials 2H 2014 Multiple Sclerosis R. Voskuhl , M.D., report detailed Phase II results 2H 2014 C - IBS Initiate Phase II clinical trial 2Q 2014 Multiple Sclerosis R. Voskuhl , M.D., report t opline Phase II results at AAN 2H 2014 C. difficile Fil
Slide 27: Mar 2014 – 3.4.2014 – FINAL2 March 2014
Mar 2014 – 3.4.2014 – FINAL2 NYSE MKT: SYN March 2014
Slide 28: References
References Slide 6: 1 Pr egnancy I n M ultiple S clerosis (PRIMS) Study; Confavreux , C., Hutchinson, M., Hours, M.M., Cortinvis - Tourniaire , P., Moreau, T., and the Pregnancy in MS Group (1998). Rate of Pregnancy - Related Relapse in Multiple Sclerosis. New England Journal of Medicine , 339, 285
Slide 29: References
References 29 Slide 18 : 15 - 16 This information is an estimate derived from the use of information under license from the following IMS Health Incorporated inf ormation service: CDM Hospital database for full year 2012. IMS expressly reserves all rights, including rights of copying, distribution a
Slide 30: References
References 30 Slide 22 : 27 Falagas , ME, Bliziotis , LA, and Siempos , II. Attributable mortality of Acinetobacter baumannii infections in critically ill patients: a systematic review of matched cohort and case - control studies. Critical Care 2006, 10:R48. 28 Barrett, L. Former VP of US Marketing
Slide 31: P1A 1st Generation Oral β-lactamase: Results of Phase I/II Clinical Trials
P1A - 1 st Generation Oral β - lactamase • P1A was studied in four (4) Phase I and one (1) Phase II clinical trials ‒ 112 patients and 143 healthy normal subjects exposed, generally: ▪ P reserved the normal intestinal microflora when co - administered with IV ampicillin or piperacillin ▪ Prevented e
Synthetic Biologics — Investor Presentation (March 2014) on 6ix